Galaxy G3

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name: GALAXY G3 FDA UDI
Generic Name: Neurovascular embolization coil FDA UDI
Device Name: GALAXY G3 Microcoil 12 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: GALAXY G3 12 Stretch Resistant Coil 8mm (coil diameter) x 15cm (coil length) 190cm (working length) FDA UDI
Model / Reference: GLY120815 FDA UDI
Description: GALAXY G3 Microcoil 12 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: GALAXY G3 12 Stretch Resistant Coil 8mm (coil diameter) x 15cm (coil length) 190cm (working length) FDA UDI

Identifiers

Catalog Number: GLY120815 FDA UDI
Primary DI / UDI-DI: 10886704077572 FDA UDI
FDA Product Code: HCG FDA UDI
KRD FDA UDI
GMDN Term: Neurovascular embolization coil FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5950 FDA UDI
870.3300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Neurovascular embolization coil

Galaxy G3 by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medos International Sàrl

Sources (1)

FDA UDI fb8dad07-2e13-42e9-b7b2-7a589f7027c2 35 fields · synced Jun 1, 2026